A Study To Evaluate Safety And Efficacy Of IV Sildenafil In The Treatment Of Neonates With Persistent Pulmonary Hypertension Of The Newborn
Purpose
This study will evaluate whether IV sildenafil can reduce the time on inhaled nitric oxide treatment and reduce the failure rate of available treatments for persistent pulmonary hypertension of the newborn.
Condition
- Pulmonary Hypertension, Familial Persistent, of the Newborn
Eligibility
- Eligible Ages
- Between 0 Days and 4 Days
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- Neonates with persistent pulmonary hypertension of the newborn - Age <=96 hours and >=34 weeks gestational age - Oxygenation Index >15 and <60 - Concurrent treatment with inhaled nitric oxide and >=50% oxygen
Exclusion Criteria
- Prior or immediate need for extracorporeal membrane oxygenation or cardiopulmonary resuscitation - Expected duration of mechanical ventilation <48 hours - Profound hypoxemia - Life-threatening or lethal congenital anomaly
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Placebo Comparator placebo |
iv placebo of normal saline or 10% dextrose |
|
|
Experimental sildenafil |
Active study drug |
|
More Details
- Status
- Completed
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.